Tissue removal system

ABSTRACT

A tissue removal device includes a housing, an outer tube having a distal portion configured for transcervical insertion into a uterus, an inner tube slidably disposed within the outer tube lumen, a vacuum generation chamber disposed within the housing, a movable piston slidably disposed in the vacuum generation chamber, a collection chamber, a manual actuator moveably coupled to the housing and operatively coupled to the piston, and proximal and distal one-way valves. The outer tube has an outer tube lumen, a tissue in-take opening proximate a distal end thereof, and a proximal end coupled to the housing. The inner tube has an inner tube lumen extending from an open inner tube distal end to an open inner tube proximal end, the open inner tube distal end comprising a cutting edge configured to sever intrauterine tissue extending through the tissue in-take opening in the outer tube.

RELATED APPLICATION DATA

The present application is a National Phase entry under 35 U.S.C § 371of International Patent Application No. PCT/US2016/062080, having aninternational filing date of Nov. 15, 2016, which claims the benefitunder 35 U.S.C. § 119 to U.S. provisional patent application Ser. No.62/255,650, filed Nov. 16, 2015. The foregoing application is herebyincorporated by reference into the present application in its entiretyas though set forth in full.

FIELD

The disclosure relates generally to methods, systems and devices forsurgical procedures, and relates more particularly to tissue removalsystems for the removal of body tissues, including uterine polyps andother abnormal gynecological tissues.

BACKGROUND

There are many situations in which it is desirable to remove unwantedtissue from a patient. Uterine polyps and uterine fibroids represent twosuch types of unwanted tissue. Uterine polyps are wispy masses that arecommonly found extending from the inner lining of the uterus. Uterinefibroids are well-defined, non-cancerous tumors that are commonly foundin the smooth muscle layer of the uterus. In many instances, uterinepolyps and uterine fibroids can grow to be several centimeters indiameter and may cause symptoms like menorrhagia (prolonged or heavymenstrual bleeding), pelvic pressure or pain, and reproductivedysfunction. It is believed that uterine polyps occur in up to 10percent of all women, and that uterine fibroids occur in a substantialpercentage of the female population, perhaps in at least 20 to 40percent of all women.

One type of treatment for uterine polyps and uterine fibroids ishysteroscopic resection. Hysteroscopic resection typically involvesinserting a hysteroscope (i.e., an imaging scope) into the uterusthrough the vagina, i.e., transcervically, and then cutting away theunwanted tissue from the uterus using a device delivered to the unwantedtissue by or through the hysteroscope. Hysteroscopic resectionstypically fall into one of two varieties. In one variety, anelectrocautery device in the form of a loop-shaped cutting wire isfixedly mounted on the distal end of the hysteroscope. The combinationof the hysteroscope and the electrocautery device is typically referredto as a resectoscope. The transmission of electrical current to theuterus with a resectoscope is typically monopolar, and the circuit iscompleted by a conductive path to the power unit for the device througha conductive pad applied to the patient's skin. In this manner, tissueis removed by contacting the loop with the part of the uterus wall ofinterest. Examples of such devices are disclosed, for example, in U.S.Pat. No. 5,906,615, issued May 25, 1999, the contents of which are fullyincorporated herein by reference as though set forth in full.

In the other variety of hysteroscopic resection, an electromechanicalcutter is inserted through a working channel in the hysteroscope. Theelectromechanical cutter typically includes (i) a tubular member havinga window through which tissue may enter and (ii) a cutting instrumentpositioned within the tubular member for cutting the tissue that hasentered the tubular member through the window. In use, a distal portionof the electromechanical cutter is positioned near the part of theuterus wall of interest. Tissue is then drawn, typically by suction,into the window, and then the tissue drawn into the window is cut withthe cutting instrument. Examples of the electromechanical cutter varietyof hysteroscopic resection are disclosed in, for example, U.S. Pat. No.9,060,760, issued Jun. 23, 2015; U.S. Pat. No. 8,062,214, issued Nov.22, 2011; U.S. Pat. No. 7,226,459, issued Jun. 5, 2007; U.S. Pat. No.6,032,673, issued Mar. 7, 2000; U.S. Pat. No. 5,730,752, issued Mar. 24,1998; U.S. Patent Application Publication No. US 2009/0270898 A1,published Oct. 29, 2009; U.S. Patent Application Publication No. US2009/0270812 A1, published Oct. 29, 2009; and PCT InternationalPublication No. WO 99/11184, published Mar. 11, 1999, the contents ofall of which are fully incorporated herein by reference as though setforth in full.

In both of the above-described varieties of hysteroscopic resection,prior to tissue removal, the uterus is typically distended to create aworking space within the uterus. Such a working space typically does notexist naturally in the uterus because the uterus is a flaccid organ. Assuch, the walls of the uterus are typically in contact with one anotherwhen in a relaxed state. The conventional technique for creating such aworking space within the uterus is to administer a fluid to the uterusthrough the hysteroscope under sufficient pressure to cause the uterusto become distended. Examples of the fluid used conventionally todistend the uterus include gases like carbon dioxide or, more commonly,liquids like water or certain aqueous solutions (e.g., a saline or otherphysiologic solution or a sugar-based or other non-physiologicsolution). For instance, a 3 L bag of saline connected to a uterus(e.g., through a hysteroscope) can generate uterine distension pressure50-60 mm of Hg.

One of the benefits of fluid distension is the tamponade effect that thedistension fluid provides on resected vascular tissue. Since thedistension fluid is typically maintained at a pressure that exceeds thepatient's mean arterial pressure (MAP), the fluid pressure provided bythe distension fluid prevents the leakage of arterial blood from theresected tissue from flowing or oozing into the uterine cavity. Whenarterial blood flows or oozes into the cavity, it mixes with thedistension fluid and renders visualization more difficult and, if notconstrained, the flowing or oozing blood will force the suspension ofthe procedure. Thus, maintenance of fluid pressure above the intracavityarterial pressure facilitates the maintenance of a clear visual field.

Nevertheless, one shortcoming with existing hysteroscopic tissue removalsystems, particularly of the electromechanical cutter variety, is thatit is often difficult to maintain fluid distension of the uterus duringthe resection procedure. This is because such systems typically employ avacuum source that continuously subjects the electromechanical cutter tosuction, even when the cutting mechanism of the electromechanical cutteris not switched on. The purpose of such suction is to draw tissue intothe cutter, typically through the window, and to facilitate the removalof resected tissue from the uterus. However, such suction also typicallyhas the unwanted effect of removing some of the distending fluid fromthe uterus along with the resected tissue. Moreover, because suction iscontinuously applied to the cutter, even when the cutting mechanism isnot being operated, fluid tends to be continuously removed from theuterus whenever the cutter is inserted into the patient. If such fluidcannot be replenished quickly enough, the fluid pressure within theuterus may drop to an undesired level. In particular, a steep drop inuterine fluid pressure will result in the leakage of blood into theuterine cavity, causing a loss of visualization and ultimately stoppageof the procedure if the surgeon can no longer properly visualize thetreatment site. Moreover, depending on the extent and speed of the dropin uterine fluid pressure, there may be a significant lapse of timebefore the uterine fluid pressure can be restored to a desired levelsuch that adequate visualization is possible. Such lapses in time areclearly undesirable as they interrupt the resection procedure, as wellas lengthen the overall time for the procedure and increase the riskthat distending fluid may be taken up by a blood vessel in the uterus,i.e., intravasation, which uptake may be quite harmful to the patient.

One approach to the above problem has been to provide theelectromechanical cutter with a mechanism actuated by an electricalswitch that causes the window in the cutter to be closed off when thecutting mechanism is turned off. In this manner, when the cuttingmechanism is switched off, only a minimal amount of distension fluid canescape from the uterus through the resection window of the cutter, andadequate uterine fluid pressure may be maintained. Unfortunately, thecost of the above-described electromechanical cutters may be prohibitivefor certain procedures, such as polypectomies, for which the costscovered by most insurers are typically relatively low.

SUMMARY

In accordance with one embodiment, a tissue removal device for acquiringone or more samples of intrauterine tissue from a patient includes ahousing. The device also includes an outer tube having a distal portionconfigured for transcervical insertion into a uterus, the outer tubehaving an outer tube lumen, a tissue in-take opening proximate a distalend thereof, and a proximal end coupled to the housing. The devicefurther includes an inner tube slidably disposed within the outer tubelumen, the inner tube having an inner tube lumen extending from an openinner tube distal end to an open inner tube proximal end, the open innertube distal end comprising a cutting edge configured to severintrauterine tissue extending through the tissue in-take opening in theouter tube. Moreover, the device includes a vacuum generation chamberdisposed within the housing. In addition, the device includes a movablepiston slidably disposed in the vacuum generation chamber so that thepiston forms a wall of the vacuum chamber. The inner tube lumen isselectively placed in fluid communication with the vacuum generationchamber via a distal one-way valve, the distal one-way valve beingoriented so that material located in the inner tube lumen may beaspirated from the inner tube lumen into the vacuum generation chamberin response to movement of the piston in a distal direction, whilematerial in the vacuum generation chamber is prevented by the distalone-way valve from entering the inner lumen. The device also includes acollection chamber. The vacuum generation chamber is selectively placedin fluid communication with the collection chamber via a proximalone-way valve, the proximal one-way valve being oriented so thatmaterial located in the vacuum generation chamber may be expelled fromthe vacuum generation chamber into the collection chamber in response tomovement of the piston in a proximal direction, while material in thecollection chamber is prevented from entering the vacuum generationchamber. The device further includes a manual actuator moveably coupledto the housing and operatively coupled to the piston, wherein movementof the actuator relative to the housing causes movement of the pistonwithin the vacuum generation chamber.

In one or more embodiments, the in-take opening is a side facing openingrelative to the outer tube. The distal one-way valve may be opened whenthe piston is moved in the distal direction and sealed when the pistonis moved in the proximal direction. The proximal one-way valve may beopened when the piston is moved in the proximal direction and sealedwhen the piston is moved in the distal direction. The material may beintrauterine tissue or fluid from within the uterus. The proximal anddistal one-way valves may be duck-billed valves.

In one or more embodiments, the device also includes a porous filtertrap in selective fluid communication with the vacuum generationchamber, the porous filter trap configured to separate excisedintrauterine tissue from fluid. The porous filter trap may be containedin the collection chamber. The porous filter trap may be selectivelyfluidly coupled to the vacuum generation chamber by the proximal one-wayvalve, so that material may pass from the vacuum generation chamber tothe porous filter trap in response to movement of the piston in aproximal direction. The porous filter trap may be integrally formed. Thedevice may also include a trap housing configured to releasably securethe porous filter trap onto the housing. The outer tube may include anedge adjacent the tissue in-take opening configured to facilitatecollection of intrauterine tissue adjacent the tissue in-take opening.When the actuator is fully actuated, a volume of the vacuum generationchamber may be about three times a volume of the inner tube lumen.

In one or more embodiments, the proximal and distal one-way valves areconfigured such that, when the piston is not moving and the uterus isdistended by distension fluid, both the proximal and distal one-wayvalves are open under pressure from the distension fluid. The proximaland distal one-way valves may be configured such that, when the pistonis not moving and the uterus is distended by distension fluid, thedistension fluid flows through the proximal and distal one-way valves.The distension fluid may urge intrauterine tissue through the tissuein-take opening and into an outer tube lumen. The proximal and distalone-way valves may each have a cracking pressure of about 40 mm Hg andthe distension fluid may generate a distension pressure between about 50mm Hg and about 60 mm Hg. The distal one-way valve may be at leastpartially formed in the piston.

In one or more embodiments, the device also includes a valve configuredto selectively couple the inner tube lumen with a vacuum source externalto the housing. The valve may be a pinch valve.

In one or more embodiments, the manual actuator may be operativelycoupled to the inner tube such that movement of the actuator relative tothe housing causes longitudinal movement of the inner tube within theouter tube lumen. The device may also include a cam and a cam followeroperatively coupled to the inner tube and the housing such that movementof the actuator relative to the housing causes longitudinal androtational movement of the inner tube within the outer tube lumen. Thecam may be fixed to the inner tube and the cam follower may be fixed tothe housing. The cam may be fixed to the housing and the cam followermay be fixed to the inner tube.

In one or more embodiments, the device also includes a yoke selectivelycoupling the manual actuator to the inner tube. When the manual actuatoris coupled to the inner tube, movement of the actuator relative to thehousing causes longitudinal movement of the piston within the vacuumgeneration chamber and the inner tube within the outer tube lumen. Whenthe manual actuator is uncoupled from the inner tube, longitudinalmovement of the actuator relative to the housing causes the pistonwithin the vacuum generation chamber without longitudinal movement ofthe inner tube within the outer tube lumen. The device may include aknob configured to rotate the outer tube relative to the housing tochange a circumferential position of the opening.

In accordance with one embodiment, a tissue removal device for acquiringone or more samples of intrauterine tissue from a patient includes ahousing. The device also includes an outer tube having a distal portionconfigured for transcervical insertion into a uterus, the outer tubehaving an outer tube lumen, a tissue in-take opening proximate a distalend thereof, and a proximal end coupled to the housing. The devicefurther includes an inner tube slidably disposed within the outer tubelumen, the inner tube having an inner tube lumen extending from an openinner tube distal end to an open inner tube proximal end, the open innertube distal end comprising a cutting edge configured to severintrauterine tissue extending through the tissue in-take opening in theouter tube. Moreover, the device includes a vacuum generation chamberdisposed within the housing. In addition, the device includes a bellowsdisposed within the housing and having a movable wall and a vacuumgeneration chamber. The inner tube lumen is selectively placed in fluidcommunication with the vacuum generation chamber via a distal one-wayvalve, the distal one-way valve being oriented so that material locatedin the inner tube lumen may be aspirated from the inner tube lumen intothe vacuum generation chamber in response to movement of the wall of thebellows in a distal direction, while material in the vacuum generationchamber is prevented by the distal one-way valve from entering the innerlumen. The device also includes a collection chamber. The vacuumgeneration chamber is selectively placed in fluid communication with thecollection chamber via a proximal one-way valve, the proximal one-wayvalve being oriented so that material located in the vacuum generationchamber may be expelled from the vacuum generation chamber into thecollection chamber in response to movement of the wall of the bellows ina proximal direction, while material in the collection chamber isprevented from entering the vacuum generation chamber. The devicefurther includes a manual actuator moveably coupled to the housing andoperatively coupled to the wall of the bellows, wherein movement of theactuator relative to the housing causes movement of the wall of thebellows within the vacuum generation chamber. In one or moreembodiments, the wall of the bellows is a distal wall.

Additional objects, as well as aspects, features and advantages, of thedisclosure are set forth in part in the description which follows, andin part will be obvious from the description or may be learned bypractice of the invention. In the description, reference is made to theaccompanying drawings which form a part thereof and in which is shown byway of illustration various embodiments for practicing the invention.The embodiments will be described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is to be understoodthat other embodiments may be utilized and that structural changes maybe made without departing from the scope of the disclosed inventions.The following detailed description is, therefore, not to be taken in alimiting sense, and the scope of the disclosure is best defined by theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of embodiments of thedisclosed inventions, in which similar elements are referred to bycommon reference numerals. These drawings are not necessarily drawn toscale. In order to better appreciate how the above-recited and otheradvantages and objects are obtained, a more particular description ofthe embodiments will be rendered, which are illustrated in theaccompanying drawings. These drawings depict only typical embodiments ofthe disclosed inventions and are not therefore to be considered limitingof its scope.

FIG. 1 is a side view of a first embodiment of a tissue removal deviceconstructed according to the teachings of the disclosure, with anactuator of the tissue removal device in an un-actuated state, and witha portion of a housing removed;

FIG. 2 is a side view of the tissue removal device depicted in FIG. 1,with the actuator of the tissue removal device in an actuated state, andwith a portion of the housing removed;

FIG. 3 is a detailed cross-sectional side view of respective distal endsof outer and inner tubular members of the tissue removal device depictedin FIG. 1, with the actuator of the tissue removal device in anun-actuated state.

FIG. 4 is a detailed cross-sectional side view of respective distal endsof outer and inner tubular members of the tissue removal device depictedin FIG. 1, with the actuator of the tissue removal device in an actuatedstate.

FIG. 5 is a side view of a second embodiment of a tissue removal deviceconstructed according to the teachings of the disclosure, with anactuator of the tissue removal device in an un-actuated state;

FIGS. 6-8 are increasingly detailed cross-sectional side views of thetissue removal device depicted in FIG. 5, with the actuator of thetissue removal device in an un-actuated state;

FIG. 9 is a detailed cross-sectional side view of the tissue removaldevice depicted in FIG. 5, with the actuator of the tissue removaldevice in an actuated state;

FIG. 10 is a side view of the tissue removal device depicted in FIG. 5,with the actuator of the tissue removal device in an un-actuated state;

FIGS. 11 and 12 are increasingly detailed perspective views of thetissue removal device depicted in FIG. 5 showing a tissue trap housing,with the actuator of the tissue removal device in an un-actuated state;

FIG. 13 is a detailed cross-sectional side view of respective distalends of outer and inner tubular members of the tissue removal devicedepicted in FIG. 5, with the actuator of the tissue removal device in anun-actuated state.

FIG. 14 is a detailed cross-sectional side view of respective distalends of outer and inner tubular members of the tissue removal devicedepicted in FIG. 5, with the actuator of the tissue removal device in anactuated state.

FIGS. 15 and 16 are detailed perspective views of distal ends of theouter tubular members of tissue removal devices according to twoembodiments.

FIGS. 17 and 18 are increasingly detailed cross-sectional side views ofa third embodiment of a tissue removal device constructed according tothe teachings of the disclosure showing a motion conversion system, withan actuator of the tissue removal device in an un-actuated state;

FIG. 19 is a detailed perspective view of the tissue removal devicedepicted in FIGS. 17 and 18 showing the motion conversion system, withthe actuator of the tissue removal device in an un-actuated state.

FIGS. 20 and 21 are detailed cross-sectional side views of a fourthembodiment of a tissue removal device constructed according to theteachings of the disclosure showing a bellows, with an actuator of thetissue removal device in un-actuated and actuated states, respectively.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skilled in the art wouldconsider equivalent to the recited value (i.e., having the same functionor result). In many instances, the terms “about” may include numbersthat are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

As used in this application, a “tubular member” is any elongate devicehaving a lumen. The lumen may extend the entire length of the elongatedevice (i.e., from a first end to a second, opposite end), or the lumenmay extend less than the entire length of the elongate device. A tubularmember can be formed from any material, including, but not limited to,metals and polymers. While the tubular members described herein havesubstantially circular cross-sectional geometry, tubular members mayhave any cross-sectional geometry, including one that changes along thelongitudinal axis of the device. Therefore, uses of terms that connotecircular geometry, such as “radius,” “diameter,” “circumference,” and“annular,” are illustrative, and not intended to be limiting.Accordingly, such terms are intended to include analogous concepts intubular members having non-circular geometries.

Conditional language, such as, among others, “can,” “could,” “might,” or“may,” unless specifically stated otherwise, or otherwise understoodwithin the context as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements and/or steps are inany way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or without userinput or prompting, whether these features, elements and/or steps areincluded or are to be performed in any particular embodiment. Theheadings used herein are for the convenience of the reader only and arenot meant to limit the scope of the inventions or claims.

Various embodiments are described hereinafter with reference to thefigures. The figures are not necessarily drawn to scale, the relativescale of select elements may have been exaggerated for clarity, andelements of similar structures or functions are represented by likereference numerals throughout the figures. It should also be understoodthat the figures are only intended to facilitate the description of theembodiments, and are not intended as an exhaustive description of theinvention or as a limitation on the scope of the invention, which isdefined only by the appended claims and their equivalents. In addition,an illustrated embodiment needs not have all the aspects or advantagesshown. An aspect or an advantage described in conjunction with aparticular embodiment is not necessarily limited to that embodiment andcan be practiced in any other embodiments even if not so illustrated.

The disclosure is described below primarily in the context of devicesand procedures optimized for performing one or more therapeutic ordiagnostic gynecological or urological procedures such as the removal ofuterine polyps or other uterine tissue. However, the devices and relatedprocedures of the disclosure may be used in a wide variety ofapplications throughout the body, through a variety of access pathways.

For example, the devices of the disclosure can be optimized for use viaopen surgery, less invasive access such as laparoscopic access, orminimally invasive procedures such as via percutaneous access. Inaddition, the devices of the disclosure can be configured for access toa therapeutic or diagnostic site via any of the body's natural openingsto accomplish access via the ears, nose, mouth, and via trans-rectal,urethral and vaginal approach.

In addition to the performance of one or more gynecological and urologicprocedures described in detail herein, the systems, methods, apparatusand devices of the disclosure may be used to perform one or moreadditional procedures, including, but not limited to, access to andtissue manipulation or removal from any of a variety of organs such asthe bladder, breast, lung, stomach, bowel, esophagus, oral cavity,rectum, nasal sinus, Eustachian tubes, heart, gall bladder, arteries,veins, and various ducts. Routes of access include but are not limitedto trans-cervical; trans-vaginal-wall; trans-uteral; trans-vesicle;trans-urethral; and other routes.

FIGS. 1-4 illustrate an embodiment of a tissue removal device 100 inrespective un-actuated (FIGS. 1 and 3) and actuated (FIGS. 2 and 4)states (described below). The tissue removal device 100 includesmanually operated assemblies (also described below) for creating vacuumand for cutting tissue. As used in this application, “vacuum” includesbut is not limited to, a pressure differential sufficient to movematerial (e.g., excised tissue and fluid) from one space to anotherspace. As such, the tissue removal device 100 is capable of performing atissue removal procedure (e.g., a polypectomy) with no external vacuumor power sources, and is therefore a “tetherless” or “non-tethered”device. This is in contrast to “tethered” tissue removal devices, whichrequire various external power sources, motors, and/or vacuums toperform tissue removal procedures.

The tissue removal device 100 includes a housing 102 having a proximalend 104 and a distal end 106. The tissue removal device 100 alsoincludes an outer tubular member 108 having a proximal end 110 rotatablycoupled to the distal end 106 of the housing 102 and a distal end 112having a proximal tissue receiving window/tissue in-take opening 114, asbest shown in FIGS. 3 and 4. The outer tubular member 108 also includesa grip/rotator/knob 116 configured to facilitate user rotation of therotatably coupled outer tubular member 108. The rotator 116 is disposedadjacent and fixed to the proximal end 110 of the outer tubular member108. In this manner, the outer tubular member 108 is configured toselectively rotate relative to the housing 102 in response tomanipulation of the rotator 116 to alter the circumferential position ofthe tissue receiving window 114. The tissue removal device 100 furtherincludes an inner tubular member 118 configured for axial movementwithin an outer tubular member lumen 148 in the outer tubular member108, as shown in FIGS. 3 and 4. The outer and inner tubular members 108,118 can be either flexible or rigid.

The outer tubular member 108 may be configured for transcervicalinsertion. Additionally or alternatively, the outer tubular member 108may be configured for insertion through a working channel of anendoscopic instrument so that the tissue receiving window 114 isdisposed in an interior region of a patient's body. The distal end 112of the outer tubular member 108 may be conformable or rigid. The innertubular member 118 is hollow, and includes an open proximal end, an opendistal end 122, and an inner tubular member lumen 150 (see FIGS. 3 and4) extending between the open proximal end 120 and the open distal end122. The distal end 122 of the inner tubular member 118 includes acutting edge 124 (e.g., annular) for severing tissue projecting into thetissue receiving window 114 as the inner tubular member 118 moves pastthe tissue receiving window 114 (see FIGS. 3 and 4).

The tissue removal device 100 also includes a manually operatedactuator, or trigger 126 rotatably coupled to the housing 102 by apinned connection 130, which acts as a pivot point, such that thetrigger 126 is configured to rotate about the pinned connection 130. Thetrigger 126 includes a first end 132 disposed inside of the housing 102,and a second end 134 disposed outside of the housing 102. The trigger126 is rotatably coupled to the housing 102 such that a user may holdthe housing 102 in one hand and actuate the trigger 126 by squeezing thesecond end 134 of the trigger 126 toward the housing 102. Actuating thetrigger 126 by squeezing rotates the second end 134 of the trigger 126toward the housing 102 about the pivot point formed by the pinnedconnection 130. A spring 128 is configured to bias the second end 134 ofthe trigger 126 away from the housing 102, as shown in FIG. 1. As aresult, when the trigger 126 is released after being actuated, thespring 128 restores the second end 134 of the trigger 126 to itsun-actuated position away from the housing 102. The spring 128 may becoupled to the housing 102 and the first end 132 of the trigger 126. Itshould be understood that the individual components of the device 100illustrated in FIGS. 1-4 are not necessarily drawn to scale. Further,FIGS. 1-4 are provided to illustrate the principles of the disclosedembodiments, and are not intended to be limiting.

The first end 132 of the trigger 126 is coupled to a piston/plunger 136,which forms a movable distal wall of a vacuum generation chamber 138,thereby enabling the vacuum generation chamber 138 to change its volumewith movement of the piston/plunger 136. Actuating the trigger 126rotates the first end 132 of the trigger 126 about the pinned connection130, and moves the piston 136 relative to a proximal wall of the vacuumgeneration chamber 138. In particular, actuating the second end 134 ofthe trigger 126 toward the housing 102 causes the piston 136 to bepulled distally away from the proximal wall of the vacuum generationchamber 138, thereby increasing the volume of the vacuum generationchamber 138 and reducing the pressure therein to generate vacuum, asshown in FIG. 2. In one embodiment, when the trigger 126 is fullyactuated (i.e., moved maximally toward the housing 102), a volume of thevacuum generation chamber 138 is increased to about three times a volumeof the inner tubular member lumen 150. In some embodiments, this volumeratio optimizes vacuum generation and tissue travel through the innertubular member lumen 150, and minimizes tissue clogging therein.

Releasing the trigger 126 allows the spring 128 to restore the secondend 134 of the trigger 126 to its un-actuated position away from thehousing 102. When the trigger 126 is restored to its un-actuatedposition, the piston 136 is pushed proximally toward the proximal wallof the vacuum generation chamber 138, thereby decreasing the volume ofthe vacuum generation chamber 138 and increasing the pressure therein,as shown in FIG. 1.

The proximal end 120 of the inner tubular member 118 may be fluidlycoupled to and/or form part of the piston/plunger 136. The vacuumgeneration chamber 138 is selectively fluidly coupled to the proximalend 120 of the inner tubular member 118 through a distal one-way valve140 (e.g., a duck-bill valve). The distal one-way valve 140 may befluidly coupled to and/or form a part of a proximal end of thepiston/plunger 136. The distal one-way valve 140 is configured to openwhen vacuum is generated in the vacuum generation chamber 138, therebyallowing severed tissue and/or fluid to be drawn from the inner tubularmember lumen 150 into the vacuum generation chamber 138. The distalone-way valve 140 is also configured to close when pressure is increasedin the vacuum generation chamber 138, thereby preventing severed tissueand/or fluid from being pushed from the vacuum generation chamber 138into the inner tubular member lumen 150.

In particular, the distal one-way valve 140 is configured to open whenthe pressure distal of the distal one-way valve 140 (i.e., in the innertubular member lumen 150) (the “distal pressure”) is approximately 20 mmHg to 120 mm Hg greater than the pressure proximal of the distal one-wayvalve 140 (i.e., in the vacuum generation chamber 138) (the “proximalpressure”). Preferably, the distal one-way valve 140 is configured toopen when the distal pressure is approximately 50 mm Hg greater than theproximal pressure. The distal one-way valve 140 is also configured toremain at least partially open as long as the distal pressure is atleast approximately 50 mm Hg greater than the proximal pressure. Whenthe distal pressure is less than approximately 50 mm Hg greater than theproximal pressure (or the proximal pressure is greater than the distalpressure), the distal one-way valve 140 will be closed.

The vacuum generation chamber 138 is also selectively fluidly coupled toa specimen collection chamber 142 through a proximal one-way valve 144(e.g., a duck-bill valve). The proximal one-way valve 144 may be fluidlycoupled to or form a part of a distal end of a connector 146 fluidlycoupling the vacuum generation chamber 138 to the specimen collectionchamber 142. The proximal one-way valve 144 is configured to open when apressure in the vacuum generation chamber 138 is greater than a pressurein the specimen collection chamber 142 (i.e., the reverse of the distalone-way valve 140), thereby allowing severed tissue and/or fluid to bepushed from the vacuum generation chamber 138 into the specimencollection chamber 142. The proximal one-way valve 144 is alsoconfigured to close when vacuum is generated in the vacuum generationchamber 138 (i.e., the reverse of the distal one-way valve 140), therebypreventing severed tissue and/or fluid (e.g., air) from being drawn fromproximal portions of the device 100 (e.g., the specimen collectionchamber 142 or the connector 146) into the vacuum generation chamber138.

In particular, the proximal one-way valve 144 is configured to open whenthe pressure distal of the proximal one-way valve 144 (i.e., in thevacuum generation chamber 138) (the “distal pressure”) is approximately20 mm Hg to 120 mm Hg greater than the pressure proximal of the proximalone-way valve 144 (i.e., in the connector 146 and the specimencollection chamber 142) (the “proximal pressure”). Preferably, theproximal one-way valve 144 is configured to open when the distalpressure is approximately 50 mm Hg greater than the proximal pressure.The proximal one-way valve 144 is also configured to remain at leastpartially open as long as the distal pressure is at least approximately50 mm Hg greater than the proximal pressure. When the distal pressure isless than approximately 50 mm Hg greater than the proximal pressure (orthe proximal pressure is greater than the distal pressure), the proximalone-way valve 144 will be closed.

While in this embodiment, the pressure differentials are achieved bychanging the pressure in the vacuum generation chamber 138, the pressuredifferentials can also be achieved by changing the pressure in the innertubular member lumen 150 (for the distal one-way valve 140), and theconnector 146 and the specimen collection chamber 142 (for the proximalone-way valve 144). In embodiments where the distal and proximal one-wayvalves 140, 144 are duck-billed valves, the “bills” are facingproximally to allow severed tissue and fluid to travel from the innertubular member lumen 150 into the vacuum generation chamber 138, andthen into the connector 146 and the specimen collection chamber 142.This valve configuration also minimizes backflow of allow severed tissueand fluid from the specimen collection chamber 142 and the connector 146into the vacuum generation chamber 138, and then into the inner tubularmember lumen 150.

The proximal end 120 of the inner tubular member 118 is eitherphysically coupled to or forms part of the piston/plunger 136.Accordingly, actuating the trigger 126 also moves the inner tubularmember 118 longitudinally/axially within the outer tubular member 108.The distance covered by the inner tubular member 118 during actuatingthe trigger 126 is greater than the length of the tissue receivingwindow 114 in the outer tubular member 108. Actuating the trigger 126rotates the trigger 126 about the pinned connection 130, and moves theinner tubular member 118 relative to the outer tubular member 108. Inparticular, actuating the second end 134 of the trigger 126 toward thehousing 102 causes the inner tubular member 118 to be pushed distallywithin the outer tubular member 108, as shown in FIGS. 2 and 4. Distalmovement of the inner tubular member 118 within the outer tubular member108 moves the cutting edge 124 at the distal end 122 of the innertubular member 118 across the tissue receiving window 114, therebysevering any tissue prolapsing through the tissue receiving window 114,as shown in FIG. 4 (without the tissue). The tissue removal device 100is configured such that the vacuum generated in the vacuum generationchamber 138 by actuating the trigger 126 draws tissue into the tissuereceiving window 114 before the cutting edge 124 severs the tissue. Thedevice 100 is also configured such that the vacuum generated in thevacuum generation chamber 138 by actuating the trigger 126 also drawssevered tissue from the inner tubular member lumen 150 into the vacuumgeneration chamber 138 through the open distal one-way valve 140 (whenthere is low pressure in the vacuum generation chamber 138). The device100 is further configured such that sufficient vacuum to pull tissueinto the tissue receiving window and to pull severed tissue into thevacuum generation chamber 138 is created within the vacuum generationchamber 138 with a single squeeze of the trigger 126.

Releasing the trigger 126 allows the spring 128 to restore the trigger126 to its un-actuated position with the second end 134 away from thehousing 102. When the trigger 126 is restored to its un-actuatedposition, the inner tubular member 118 is pulled proximally within theouter tubular member 108, as shown in FIGS. 1 and 3. Proximal movementof the inner tubular member 118 within the outer tubular member 108opens the tissue receiving opening as shown in FIG. 3. The tissueremoval device 100 is configured such that the pressure generated in thevacuum generation chamber 138 by (e.g., the spring 128) restoring thetrigger 126 to its un-actuated position pushes severed tissue from thevacuum generation chamber 138 into the specimen collection chamber 142before the proximally traveling piston/plunger 136 reduces volume of thevacuum generation chamber 138 to less than the volume of the severedtissue. The device 100 is also configured such that sufficient pressureto push severed tissue into the specimen collection chamber 142 iscreated within the vacuum generation chamber 138 with a singlerestoration of the trigger 126 (e.g., by the spring 128).

As described above, each time the trigger 126 is actuated/squeezed,vacuum is created by the distally moving piston 136 in the vacuumgeneration chamber 138 and immediately applied to the tissue through theinner tubular member 118, pulling the tissue into the tissue receivingwindow 114 (see FIG. 4). Further, each time the trigger 126 isactuated/squeezed, the cutting edge 124 travels distally over the tissuereceiving window 114, severing tissue prolapsing therethrough. Moreover,the vacuum generated by each trigger 126 actuation/squeeze also opensthe distal one-way valve 140 and draws severed tissue (either from thecurrent or a previous stroke) from the inner tubular member lumen 150into the vacuum generation chamber 138.

Similarly, each time the spring 128 restores the trigger 126 to itsun-actuated position, pressure is created by the proximally movingpiston 136 in the vacuum generation chamber 138. The pressure in thevacuum generation chamber 138 closes the distal one-way valve 140 andopens the proximal one-way valve 144 due to the respective pressuredifferentials as described above. The pressure in the vacuum generationchamber 138 also pushes the severed tissue (if any) and fluid thereinthrough the open proximal one-way valve 144, through the connector 146and into the specimen collection chamber 142. As a result, any tissue orfluid (including air) drawn into the device 100 by the vacuum duringtrigger 126 actuation is off-set by an equal volume of tissue and/orfluid that is ejected into the specimen collection chamber 142 (whichmay have a pressure vent during trigger 126 restoration, therebypreventing build-up of pressure in the device 100.)

Further, each time the trigger 126 is restored, the cutting edge 124travels proximally across the tissue receiving window 114, opening thetissue receiving window 114 by moving the inner tubular member 118previously blocking the window 114 proximally away from the window 114(see FIG. 3). As such, repeatedly actuating the trigger 126 of thetissue removal device 100 efficiently severs tissue, and moves thesevered tissue, using vacuum and pressure from the vacuum generationchamber 138, through the device 100 and into the specimen collectionchamber 142. At the completion of a tissue removal procedure, thespecimen collection chamber 142 with the severed tissue therein, can beremoved from the device 100. In other embodiments, each time the trigger126 is actuated/squeezed, the inner tubular member 118 and its cuttingedge 124 are also rotated to facilitate tissue cutting along with theaxial reciprocation. For instance, the tissue removal device can includea cam and cam follower (neither shown in FIGS. 1-4) or other componentsto transfer the actuation motion to rotation of the cutting edge 124 ofthe inner tubular member 118. An embodiment with a rotating innertubular member is described below in FIGS. 17-19 and described below.

FIGS. 5-14 illustrate another embodiment of a tissue removal device 100′in respective un-actuated (FIGS. 8 and 10-12 and actuated (FIG. 9)states. The tissue removal device 100′ includes manually operatedassemblies for creating vacuum and for cutting tissue (described below).These vacuum generation and tissue cutting assemblies of the tissueremoval device 100′ are structurally and operationally similar to thevacuum generation and tissue cutting assemblies of the tissue removaldevice 100 depicted in FIGS. 1-4 and described above. Like the tissueremoval device 100 depicted in FIGS. 1-4, the tissue removal device 100′depicted in FIGS. 5-12 is capable of performing a tissue removalprocedure (e.g., a polypectomy) with no further components, and istherefore also a “tetherless” device.

FIG. 5 depicts the tissue removal device 100′ in an external side view.The tissue removal device 100′ includes a pistol-shaped housing 102′.The more pistol-like shape of the tissue removal device 100′ results inthe tissue removal device 100′ having a handle 152 with a bottom end 154in addition to a body 156 with a distal end 106′ and a proximal end104′. The ergonomics of the pistol-shaped housing 102′ also allows auser's hand to generate more power when actuating the tissue removaldevice 100′. FIGS. 6-8 are increasingly detailed cross-section views ofthe tissue removal device 100′ depicted in FIG. 5, with FIG. 8 showingthe specimen collection chamber 142′ formed at the proximal end 104′ ofthe housing 102′ in detail.

The tissue removal device 100′ also includes an outer tubular member108′ having a proximal end 110′ (FIG. 7) rotatably coupled to the distalend 106′ of the housing 102′ and a distal end 112′ having a tissuereceiving window 114′ (FIGS. 5 and 6). The outer tubular member 108′also includes a rotator 116′ configured to facilitate user rotation ofthe rotatably coupled outer tubular member 108′. The rotator 116′ isdisposed adjacent and fixed to the proximal end 110′ of the outertubular member 108′. In this manner, the outer tubular member 108′ isconfigured to selectively rotate relative to the housing 102′ inresponse to manipulation of the rotator 116′ to alter thecircumferential position of the tissue receiving window 114′. In otherembodiments, the rotator can be located at a proximal end of the tissueremoval device. In such embodiments, the rotation may be coupled to theouter tubular member via a series of connectors and gears. The tissueremoval device 100′ further includes an inner tubular member 118′configured for axial movement within an outer tubular member lumen 148′in the outer tubular member 108′, as shown in FIGS. 13 and 14. The outerand inner tubular members 108′, 118′ can be either flexible or rigid.

The outer tubular member 108′ may be configured for transcervicalinsertion. Additionally or alternatively, the outer tubular member 108′may be configured for insertion through a working channel of anendoscopic instrument so that the tissue receiving window 114′ isdisposed in an interior region of a patient's body. The distal end 112′of the outer tubular member 108′ may be conformable or rigid. The innertubular member 118′ is hollow, and includes an open proximal end 120′(see FIGS. 7 and 9), an open distal end 122′, and an inner tubularmember lumen 150′ (see FIGS. 13 and 14) extending between the openproximal end 120′ and the open distal end 122′. The distal end 122′ ofthe inner tubular member 118′ includes a cutting edge 124′ (e.g.,annular) for severing tissue projecting into the tissue receiving window114′ as the inner tubular member 118′ moves past the tissue receivingwindow 114′ (see FIGS. 13 and 14).

The tissue removal device 100′ also includes a manually operatedactuator, or trigger 126′ rotatably coupled to the housing 102′ by apinned connection 130′, which acts as a pivot point, such that thetrigger 126′ is configured to rotate about the pinned connection 130′.The trigger 126′ includes a first end 132′ disposed inside of thehousing 102′ in the body 156, and a second end 134′ disposed outside ofthe housing 102′. In an un-actuated state, most of the trigger 126′ isseparated from and approximately parallel to the handle 152. The trigger126′ is rotatably coupled to the housing 102′ such that a user may holdthe housing 102′ in one hand and actuate the trigger 126′ by squeezingthe second end 134′ of the trigger 126′ toward the handle 152. Actuatingthe trigger 126′ by squeezing rotates the second end 134′ of the trigger126′ toward the handle 152 about the pivot point formed by the pinnedconnection 130′. A spring 128′ [not shown?] is configured to bias thesecond end 134′ of the trigger 126′ away from the handle 152, as shownin FIGS. 5-7. As a result, when the trigger 126′ is released after beingactuated, the spring 128′ restores the second end 134′ of the trigger126′ to its un-actuated position away from the handle 152. The spring128′ may be coupled to the housing 102′ and the first end 132′ of thetrigger 126′. It should be understood that the individual components ofthe device 100′ illustrated in FIGS. 5-14 are not necessarily drawn toscale. Further, FIGS. 5-14 are provided to illustrate the principles ofthe disclosed embodiments, and are not intended to be limiting.

The first end 132′ of the trigger 126′ is coupled to a piston/plunger136′, which forms a movable distal wall of the vacuum generation chamber138′, thereby enabling the vacuum generation chamber 138′ to change itsvolume with movement of the piston/plunger 136′. Actuating the trigger126′ rotates the first end 132′ of the trigger 126′ about the pinnedconnection 130′, and moves the piston 136′ relative to a proximal wallof the vacuum generation chamber 138′. In particular, actuating thesecond end 134′ of the trigger 126′ toward the handle 152 causes thepiston 136′ to be pulled distally away from the proximal wall of thevacuum generation chamber 138′, thereby increasing the volume of thevacuum generation chamber 138′ and reducing the pressure therein togenerate vacuum, as shown in FIG. 9. In one embodiment, when the trigger126′ is fully actuated (i.e., moved maximally toward the housing 102′),a volume of the vacuum generation chamber 138′ is increased to aboutthree times a volume of the inner tubular member lumen 150′. In someembodiments, this volume ratio optimizes vacuum generation and tissuetravel through the inner tubular member lumen 150′, and minimizes tissueclogging therein.

Releasing the trigger 126′ allows the spring 128′ to restore the secondend 134′ of the trigger 126′ to its un-actuated position away from thehandle 152. When the trigger 126′ is restored to its un-actuatedposition, the piston 136′ is pushed proximally toward the proximal wallof the vacuum generation chamber 138′, thereby decreasing the volume ofthe vacuum generation chamber 138′ and increasing the pressure therein,as shown in FIG. 7.

While the tissue removal device 100′ depicted in FIGS. 5-14 generatesvacuum and pressure with a vacuum generation chamber 138′ having amovable piston/plunger 136′, other tissue removal devices mayincorporate other manual vacuum/pressure generation mechanisms. Forinstance, some the embodiment depicted in FIGS. 20 and 2 includes abellows 190 in place of a piston/plunger 136′ that forms a wall of thevacuum generation chamber 138′ depicted in FIG. 9. The bellows 190 inFIGS. 20 and 21 includes a movable or elastically deformable distal wall190 in place of a movable piston/plunger. Like the piston/plunger, thedistal wall 190 is fluidly coupled to the inner tubular member lumen150′ via a distal one-way valve 140″. The movable distal wall 190 isphysically coupled to the trigger 126′ such that actuating the trigger126′ moves the distal wall 190 distally to increase the volume of thevacuum generation chamber 138″ (compare FIGS. 20 and 21) and generatevacuum (i.e., lower pressure) therein. Further, releasing the trigger126′ (which is biased in an un-actuated configuration) moves the distalwall 190 proximally to decrease the volume of the vacuum generationchamber 138″ and increase the pressure therein. In the embodimentdepicted in FIGS. 20 and 21, the distal wall 190 is elastic (e.g., madefrom rubber) and the volume of the vacuum generation chamber 138″ can beincreased and vacuum generated therein by elasticallydeforming/stretching the rubber distal wall 190 in a distal direction.Further, the elastic restoration of the distal wall 190 can be utilizedto drive (partially or completely) longitudinal movement of the innertubular member 118 and bias the trigger 126′ in its un-actuatedconfiguration. Moreover, the distal one-way valve 140″ may be a flapvalve 140″ configured to allow proximally directed fluid flow. Replacingthe piston/plunger 136′ in FIG. 7-9 with the bellows 190 in FIGS. 20 and21 eliminates the need for a slidable O-ring assembly to prevent fluidfrom leaking around the piston/plunger 136′, thereby reducing frictionand the trigger force needed to actuate the trigger 126′. In otherembodiments, the vacuum generation chamber may be replaced and/orsupplemented with one or more peristaltic pumps, vane pumps, androtatory pump.

The proximal end 120′ of the inner tubular member 118′ may be fluidlycoupled to and/or form part of the piston/plunger 136′. The vacuumgeneration chamber 138′ is selectively fluidly coupled to the innertubular member lumen 150′ through a distal one-way valve 140′ (e.g., aduck-bill valve). The distal one-way valve 140′ may be fluidly coupledto and/or form a part of a proximal end of the piston/plunger 136′. Thedistal one-way valve 140′ is configured to open when vacuum is generatedin the vacuum generation chamber 138′, thereby allowing severed tissueand/or fluid to be drawn from the inner tubular member lumen 150′ intothe vacuum generation chamber 138′. The distal one-way valve 140′ isalso configured to close when pressure is increased in the vacuumgeneration chamber 138′, thereby preventing severed tissue and/or fluidfrom being pushed from the vacuum generation chamber 138′ into the innertubular member lumen 150′.

In particular, the distal one-way valve 140′ is configured to open whenthe pressure distal of the distal one-way valve 140′ (i.e., in the innertubular member lumen 150′) (the “distal pressure”) is approximately 40mm Hg greater than the pressure proximal of the distal one-way valve140′ (i.e., in the vacuum generation chamber 138′) (the “proximalpressure”). The distal one-way valve 140′ is also configured to remainat least partially open as long as the distal pressure is at leastapproximately 40 mm Hg greater than the proximal pressure. When thedistal pressure is less than approximately 40 mm Hg greater than theproximal pressure (or the proximal pressure is greater than the distalpressure), the distal one-way valve 140′ will be closed.

The vacuum generation chamber 138′ is also selectively fluidly coupledto a specimen collection chamber 142′ through a proximal one-way valve144′ (e.g., a duck-bill valve). The proximal one-way valve 144′ may becoupled to or form a part of the body 156 adjacent a proximal end 104′thereof. The proximal one-way valve 144′ is configured to open when apressure is increased in the vacuum generation chamber 138′ (i.e., thereverse of the distal one-way valve 140′), thereby allowing severedtissue and/or fluid to be pushed from the vacuum generation chamber 138′into the specimen collection chamber 142′. The proximal one-way valve144′ is also configured to close when vacuum is generated in the vacuumgeneration chamber 138′ (i.e., the reverse of the distal one-way valve140′), thereby preventing severed tissue and/or fluid (e.g., air) frombeing drawn from proximal portions of the device 100′ (e.g., thespecimen collection chamber 142′) into the vacuum generation chamber138′.

In particular, the proximal one-way valve 144′ is configured to openwhen the pressure distal of the proximal one-way valve 144′ (i.e., inthe vacuum generation chamber 138′) (the “distal pressure”) isapproximately 40 mm Hg greater than the pressure proximal of theproximal one-way valve 144′ (i.e., in the specimen collection chamber142′) (the “proximal pressure”). The proximal one-way valve 144′ is alsoconfigured to remain at least partially open as long as the distalpressure is at least approximately 40 mm Hg greater than the proximalpressure. When the distal pressure is less than approximately 40 mm Hggreater than the proximal pressure (or the proximal pressure is greaterthan the distal pressure), the proximal one-way valve 144′ will beclosed.

The tissue removal device 100′ also includes a porous tissue trap 158held in the specimen collection chamber 142′ by a tissue trap housing160. The tissue trap 158 is generally cylindrical with a closed proximalend and an open distal end leading to a tissue trap interior 174. Thedistal end of the tissue trap 158 is configured to mate with acorresponding flange 176 on the body 156 of the tissue removal device100′, such that excised tissue and fluid entering the specimencollection chamber 142′ must enter the tissue trap 158 before the fluidmay exit the tissue removal device 100′. The tissue trap 158 hasopenings 162 formed in the longitudinal surface thereof thatcollectively form a flow path between the tissue trap interior 176 and abottom portion 164 of the specimen collection chamber 142′. The openings162 are size to retain excised tissue in the tissue trap 158 whileallowing fluid (e.g., distention fluid) to pass through the tissue trap158 and into the bottom portion 164 of the specimen collection chamber142′. In one embodiment, the fluid passes through the openings 162 inthe tissue trap 158 by gravity separation. The fluid drains from thebottom portion 164 of the specimen collection chamber 142′ through anexternal connector 166 and outside of the tissue removal device 100′.Outside of the tissue removal device 100′, the fluid may collect in afluid trap (not shown) connected to the external connector 166. Such afluid trap may be open to atmosphere. The tissue trap 158 may be anintegrally formed (i.e., molded from a single piece of material)component, which may be made by machining a block or tube of polymer.Alternatively, the tissue trap 158 may be formed using any othermanufacturing method including, but not limited to, 3-D printing.

As shown in FIG. 8, the tissue trap housing 160 may include one or moredepressions 168 configured to hold one or more O-rings to form a fluidtight seal between the tissue trap housing 160 and the proximal end 104′of the body 156 of the tissue removal device 100′. As shown in FIGS. 11and 12, the tissue trap housing 160 may include at least one detent 170configured to cooperate with a wedge-shaped slot 172 to removably lockthe tissue trap housing 160 onto the proximal end 104′ of the body 156of the tissue removal device 100′. For instance, the tissue trap housing160 may be locked with a ¼ turn of the tissue trap housing 160 relativeto the housing 102′. After a tissue resection procedure and the excessfluid has drained out of the specimen collection chamber 142′, thetissue trap housing 160 can be removed from the proximal and 104′ of thebody 156 of the tissue removal device 100′ by twisting the tissue traphousing 160 counterclockwise to unlock and pulling proximally. After thetissue trap housing 160 has been removed, the tissue trap 158 may remainattached to the proximal end 104′ of the body 156 or the tissue trap 158may be removed with the tissue trap housing 160. In the former case, thetissue trap 158 can be removed from the proximal end 104′ of the body156. In the latter case, the tissue trap 158 can be removed from insidethe tissue trap housing 160. Then, the excised tissue can be removedfrom the tissue trap 158.

While in this embodiment, the pressure differentials are achieved bychanging the pressure in the vacuum generation chamber 138′, in otherembodiments the pressure differentials can also be achieved by changingthe pressure in the specimen collection chamber 142′ (e.g., using anexternal vacuum source). In embodiments where the distal and proximalone-way valves 140′, 144′ are duck-billed valves, the “bills” are facingproximally to allow severed tissue and fluid to travel from the innertubular member lumen 150′ into the vacuum generation chamber 138′, andthen into the specimen collection chamber 142′ and the tissue trap 158.This valve configuration also minimizes backflow of allow severed tissueand fluid from the specimen collection chamber 142′ and the tissue trap158 into the vacuum generation chamber 138′, and then into the innertubular member lumen 150′.

This valve configuration also allows fluid pressure from within theuterus to open both the distal and proximal one-way valves to allow aslow continuous flow of distension fluid out of the uterus through thetissue removal device. In one embodiment, the cracking pressure to openthe distal and proximal one-way valves is about 40 mm Hg (differencebetween distal pressure and proximal pressure). With a 3 L bag of salinehung at an elevation of at least about 0.67 m (about 26.5″) to distend auterus, the distension pressure in the uterus is about 50 mm Hg to 60 mmHg. Accordingly, the distension pressure is greater than the crackingpressure of the distal and proximal one-way valves, and there is a slowcontinuous flow of distension fluid through the tissue removal device.The continuous flow of distension fluid eliminates the need to prime thetissue removal device with saline (flush out air bubbles and othermaterial from the flow path), because the pressure differential willautomatically cause distension fluid flow and thereby prime the tissueremoval device. Further, the continuous flow of distension fluid willdraw uterine tissue (e.g., hanging polyps) into the tissue receivingwindow in the outer tubular member. This drawing of uterine tissue intothe tissue receiving window allows the entire cutting stroke of theinner tubular member across the tissue receiving window to be effectiveto resect tissue at a higher rate (e.g., g/min). Without the continuousfluid flow, vacuum may not be generated until the inner tubular memberbegins to move across the tissue receiving window, thereby rendering aportion of the cutting stroke ineffective.

The proximal end 120′ of the inner tubular member 118′ is eitherphysically coupled to or forms part of the piston/plunger 136′.Accordingly, actuating the trigger 126′ also moves the inner tubularmember 118′ longitudinally/axially within the outer tubular member 108′.The distance covered by the inner tubular member 118′ during actuatingthe trigger 126′ is greater than the length of the tissue receivingwindow 114′ in the outer tubular member 108′. Actuating the trigger 126′rotates the trigger 126′ about the pinned connection 130′, and moves theinner tubular member 118′ relative to the outer tubular member 108′. Inparticular, actuating the second end 134′ of the trigger 126′ toward thehandle 152 causes the inner tubular member 118′ to be pushed distallywithin the outer tubular member 108′, as shown in FIGS. 9 and 14. Distalmovement of the inner tubular member 118′ within the outer tubularmember 108′ moves the cutting edge 124′ at the distal end 122′ of theinner tubular member 118′ across the tissue receiving window 114′,thereby severing any tissue prolapsing through the tissue receivingwindow 114′, as shown in FIG. 14 (without the tissue). The tissueremoval device 100′ is configured such that the vacuum generated in thevacuum generation chamber 138′ by actuating the trigger 126′ drawstissue into the tissue receiving window 114′ before the cutting edge124′ severs the tissue. The device 100′ is also configured such that thevacuum generated in the vacuum generation chamber 138′ by actuating thetrigger 126′ also draws severed tissue from the inner tubular memberlumen 150′ into the vacuum generation chamber 138′ through the opendistal one-way valve 140′ (when there is low pressure in the vacuumgeneration chamber 138′). The device 100′ is further configured suchthat sufficient vacuum to pull tissue into the tissue receiving windowand to pull severed tissue into the vacuum generation chamber 138′ iscreated within the vacuum generation chamber 138′ with a single squeezeof the trigger 126′.

Releasing the trigger 126′ allows the spring 128′ to restore the trigger126′ to its un-actuated position with the second end 134′ away from thehandle 152. When the trigger 126′ is restored to its un-actuatedposition, the inner tubular member 118′ is pulled proximally within theouter tubular member 108′, as shown in FIGS. 7 and 13. Proximal movementof the inner tubular member 118′ within the outer tubular member 108′opens the tissue receiving opening as shown in FIG. 13. The tissueremoval device 100′ is configured such that the pressure generated inthe vacuum generation chamber 138′ by (e.g., the spring 128′) restoringthe trigger 126′ to its un-actuated position pushes severed tissue fromthe vacuum generation chamber 138′ into the specimen collection chamber142′ and the tissue trap 158 before the proximally travelingpiston/plunger 136′ reduces volume of the vacuum generation chamber 138′to less than the volume of the severed tissue. The device 100′ is alsoconfigured such that sufficient pressure to push severed tissue into thespecimen collection chamber 142′ and the tissue trap 158 is createdwithin the vacuum generation chamber 138′ with a single restoration ofthe trigger 126′ (e.g., by the spring 128′).

As described above, each time the trigger 126′ is actuated/squeezed,vacuum is created by the distally moving piston 136′ in the vacuumgeneration chamber 138′ and immediately applied to the tissue throughthe inner tubular member 118′, pulling the tissue into the tissuereceiving window 114′ (see FIG. 14). Further, each time the trigger 126′is actuated/squeezed, the cutting edge 124′ travels distally over thetissue receiving window 114′, severing tissue prolapsing therethrough.Moreover, the vacuum generated by each trigger 126′ actuation/squeezealso opens the distal one-way valve 140′ and draws severed tissue(either from the current or a previous stroke) from the inner tubularmember lumen 150′ into the vacuum generation chamber 138′.

Similarly, each time the spring 128′ restores the trigger 126′ to itsun-actuated position, pressure is created by the proximally movingpiston 136′ in the vacuum generation chamber 138′. The pressure in thevacuum generation chamber 138′ closes the distal one-way valve 140′ andopens the proximal one-way valve 144′ due to the respective pressuredifferentials as described above. The pressure in the vacuum generationchamber 138′ also pushes the severed tissue (if any) and fluid thereinthrough the open proximal one-way valve 144′, and into the specimencollection chamber 142′ and the tissue trap 158. As a result, any tissueor fluid (including air) drawn into the device 100′ by the vacuum duringtrigger 126′ actuation is off-set by an equal volume of tissue and/orfluid that is ejected into the specimen collection chamber 142′ and thetissue trap 158 (which may have a pressure relief valve to preventbuild-up of pressure in the device 100′ during restoration of trigger‘126). Alternatively or additionally, the specimen collection chamber142’ may be coupled by the external connector 166 to atmosphere outsideof the tissue removal device 100′. In some embodiments, the externalconnector 166 may be coupled to an external vacuum source (not shown).In such embodiments, a valve (not shown) may selectively couple theexternal connection 166 to the external vacuum source such as a pump ora syringe. An example of such a valve may be a pinch valve with theexternal connector 166 passing therethrough. The external vacuum maygenerate a pressure differential that overrides and opens both theproximal and distal one-way valves 140′, 144′.

Further, each time the trigger 126′ is restored, the cutting edge 124′travels proximally over the tissue receiving window 114′, opening thetissue receiving window 114′ by moving the inner tubular member 118′previously blocking the window 114′ proximally away from the window 114′(see FIG. 13). As such, repeatedly actuating the trigger 126′ of thetissue removal device 100′ efficiently severs tissue, and moves thesevered tissue, using vacuum and pressure from the vacuum generationchamber 138′, through the device 100′ and into the specimen collectionchamber 142′ and the tissue trap 158. At the completion of a tissueremoval procedure, the specimen collection chamber 142′ and the tissuetrap 158 with the severed tissue therein, can be removed from the device100′. In other embodiments, each time the trigger 126′ isactuated/squeezed, the inner tubular member 118′ and its cutting edge124′ are also rotated to facilitate tissue cutting along with the axialreciprocation. For instance, the tissue removal device can include a camand cam follower (neither shown in FIGS. 5-14) or other components totransfer the actuation motion to rotation of the cutting edge 124′ ofthe inner tubular member 118′. An embodiment with a rotating innertubular member is described below in FIGS. 17-19 and described below.

FIGS. 15 and 16 depict two embodiments of distal ends 112A, 112B ofrespective outer tubular members 108A, 108B that are configured toacquire tissue (e.g., endometrial tissue) using the respective tissueremoval devices connected thereto. The distal ends 112A, 112B depictedin FIGS. 15 and 16 can form parts of the tissue removal devices 100,100′ depicted in FIGS. 1-4 and 5-14, respectively, or other tissueremoval devices having features similar to features of the tissueremoval devices 100, 100′.

Each of the distal ends 112A, 112B includes an edge 178A, 178B atrespective distal ends of respective tissue receiving windows 114A,114B. The edges 178A, 178B are substantially orthogonal to thelongitudinal axes of the respective outer tubular members 108A, 108B.Accordingly, when the outer tubular members 108A, 108B are draggedacross a tissue surface (e.g., the endometrium), tissue can enter therespective tissue receiving windows 114A, 114B and collect therein asthe tissue is scraped by the respective edges 178A, 178B. After thetissue enters the respective tissue receiving windows 114A, 114B, it canbe prolapsed by the vacuum generated by the respective tissue removaldevices as described above. In some procedures, it may be suitable tocollect the tissue using the vacuum with or without cutting by areciprocating inner tubular member.

In some embodiments, like those described in U.S. Pat. No. 9,060,760,the tissue removal device can operate in a “vacuum mode” and a “cuttingmode.” The foregoing patent is hereby incorporated by reference into thepresent application in its entirety as though set forth in full. In suchembodiments, like the embodiments described above, the trigger isoperatively coupled to the piston/plunger. However, in such embodiments,the trigger may be selectively operatively coupled to the inner tubularmember via a yoke, which can be manipulated to select whether thetrigger is operatively coupled to or uncoupled from the inner tubularmember. For instance, in the cutting mode, the yoke may be placed in aconfiguration such that the trigger is operatively coupled to the innertubular member. Consequently, in the cutting mode, actuating the triggerwill move both the inner tubular member (to cut tissue prolapsingthrough the tissue receiving window) and the piston/plunger to delivervacuum. In the vacuum mode, the yoke may be placed in a configurationsuch that the tissue is prolapsing through the tissue receiving windowwhile the trigger is operatively uncoupled from the inner tubularmember. Consequently, in the vacuum mode, actuating the trigger willmove the piston/plunger to generate vacuum, without moving the innertubular member. In the vacuum mode, the outer tubular member of thetissue removal device can be used as a pipelle (e.g., an endometrialpipelle) to remove tissue (e.g., endometrial tissue) by scraping acrossa tissue surface. In such embodiments, the distal ends 112A, 112Bdepicted in FIGS. 15 and 16 can help to remove tissue by scraping.

FIGS. 17-19 depict a tissue removal device 100″ according to stillanother embodiment. In particular, FIGS. 17-19 illustrate a motionconversion system 180 configured to convert linear (e.g.,longitudinal/axial) motion of the inner tubular member 118″ relative tothe housing 102″ and the outer tubular member into rotational motion ofthe inner tubular member 118″ relative to the housing 102″ and the outertubular member. The motion conversion system 180 includes an innertubular member holder 182 physically coupled to the inner tubular member118″ such that the inner tubular member holder 182 and the inner tubularmember 118″ move both longitudinally and rotationally together. Theinner tubular member holder 182 includes a helical groove 184 (i.e., acam) that spirals around the longitudinal axes of both the inner tubularmember holder 182 and the inner tubular member 118″. The motionconversion system 180 also includes a cam follower 186 (FIG. 19)physically coupled on an inner surface of the housing 102″ such that itis stationary relative to the housing 102″. In some embodiments, the camfollower 186 may be formed on the inner surface of the housing 102″.

As shown in FIG. 19, the cam follower 186 is disposed in the helicalgroove 184 and sized and shaped to travel back and forth along thespiral/helix therein. Accordingly, when the inner tubular member 118″moves distally (driven by the trigger to cut tissue prolapsing throughthe tissue receiving window), the interaction between the helical groove184 in the inner tubular member holder 182 and the cam follower 186causes the inner tubular member holder 182 and the inner tubular member118″ coupled thereto to rotate relative to the housing 102″ and theouter tubular member. The inner tubular member 118″ may be rotatablysupported by a barrel 188 portion of the housing 102″. Rotation of theinner tubular member 118″ also rotates the cutting edge 124 located at adistal end thereof (see FIGS. 3, 4, 13 and 14). Rotating the cuttingedge 124 while advancing same over prolapsing tissue increases theefficiency with which the cutting edge 124 severs the tissue. Thisincreased cutting efficiency particularly benefits cutting of morefibrous tissue using a cutting instead of a shearing mechanism. In someembodiments, the

In the embodiment depicted in FIG. 19, translating the inner tubularmember holder 182 from a proximal most position to a distal mostposition will rotate the inner tubular member 118″ approximately twice.Other embodiments may have different helical grooves that result indifferent numbers of rotations per stroke. For instance, if the innertubular member holder is configured to translate only a portion of itslength per stroke, the motion conversion system may generate half arotation per stroke.

In some embodiments, the piston may rotate along with the inner tubularmember. In other embodiments, the inner tubular member may belongitudinally coupled to the piston, but free to rotate relative to thepiston.

The motion conversion system 180 depicted in FIGS. 17-19 and describedabove can be used with many embodiments of tissue removal devicesincluding, but not limited to, those depicted in FIGS. 1-4 and 5-14.While the motion conversion system 180 depicted in FIGS. 17-19 include ahelical groove 184 coupled to an inner tubular member 118″ and a camfollower 186 coupled to a housing 102″, other motion conversion systemsmay have alternative mechanisms for converting linear motion torotation. For instance, an alternative motion conversion system mayinclude a helical groove coupled to a housing and a cam followingcoupled to an inner tubular member.

-   -   Although this disclosure has been provided in the context of        certain embodiments and examples, it will be understood by those        skilled in the art that the disclosure extends beyond the        specifically disclosed embodiments to other alternative        embodiments and/or uses of the embodiments and obvious        modifications and equivalents thereof. Additionally, the skilled        artisan will recognize that any of the above-described methods        can be carried out using any appropriate apparatus. Further, the        disclosure herein of any particular feature, aspect, method,        property, characteristic, quality, attribute, element, or the        like in connection with an embodiment can be used in all other        embodiments set forth herein. Thus, it is intended that the        scope of the present inventions disclosed herein should not be        limited to the illustrated and/or described embodiments. It will        be understood by those skilled in the art that various changes        and modifications may be made (e.g., the dimensions of various        parts) without departing from the scope of the disclosed        inventions, which is to be defined only by the following claims        and their equivalents. The specification and drawings are,        accordingly, to be regarded in an illustrative rather than        restrictive sense.

The invention claimed is:
 1. A tissue removal device for acquiring one or more samples of intrauterine tissue from a patient, the tissue removal device comprising: a housing; an outer tube having a distal portion configured for transcervical insertion into a uterus, the outer tube having an outer tube lumen, a tissue in-take window proximate a closed distal end thereof, and a proximal end coupled to the housing; an inner tube slidably disposed within the outer tube lumen, the inner tube having an inner tube lumen extending from an open inner tube distal end to an open inner tube proximal end, wherein the open inner tube distal end severs intrauterine tissue extending through the tissue in-take window in the outer tube when the inner tube moves from a window open position to a window-closed position; a vacuum generation chamber disposed within the housing; a movable piston slidably disposed in the vacuum generation chamber, so that the piston forms a wall of the vacuum chamber, wherein the inner tube lumen is selectively placed in fluid communication with the vacuum generation chamber via a distal one-way valve, the distal one-way valve being oriented so that material located in the inner tube lumen may be aspirated from the inner tube lumen into the vacuum generation chamber in response to movement of the piston in a distal direction, while material in the vacuum generation chamber is prevented by the distal one-way valve from entering the inner lumen; a collection chamber, wherein the vacuum generation chamber is selectively placed in fluid communication with the collection chamber via a proximal one-way valve, the proximal one-way valve being oriented so that material located in the vacuum generation chamber may be expelled from the vacuum generation chamber into the collection chamber in response to movement of the piston in a proximal direction, while material in the collection chamber is prevented from entering the vacuum generation chamber; and a manual actuator moveably coupled to the housing and operatively coupled to the piston, wherein movement of the actuator relative to the housing causes movement of the piston within the vacuum generation chamber.
 2. The tissue removal device of claim 1, wherein the in-take window is a side facing opening relative to the outer tube.
 3. The tissue removal device of claim 1, wherein the distal one-way valve is opened when the piston is moved in the distal direction and sealed when the piston is moved in the proximal direction.
 4. The tissue removal device of claim 1, wherein the proximal one-way valve is opened when the piston is moved in the proximal direction and sealed when the piston is moved in the distal direction.
 5. The tissue removal device of claim 1, wherein the proximal and distal one-way valves are duck-billed valves.
 6. The tissue removal device of claim 1, further comprising a porous filter trap in selective fluid communication with the vacuum generation chamber, the porous filter trap configured to separate excised intrauterine tissue from fluid.
 7. The tissue removal device of claim 6, wherein the porous filter trap is contained in the collection chamber.
 8. The tissue removal device of claim 6, wherein the porous filter trap is selectively fluidly coupled to the vacuum generation chamber by the proximal one-way valve, so that material may pass from the vacuum generation chamber to the porous filter trap in response to movement of the piston in a proximal direction.
 9. The tissue removal device of claim 1, wherein the outer tube comprises an edge adjacent the tissue in-take window configured to facilitate collection of intrauterine tissue adjacent the tissue in-take window.
 10. The tissue removal device of claim 1, wherein the proximal and distal one-way valves are configured such that, when the piston is not moving and the uterus is distended by distension fluid, both the proximal and distal one-way valves are open under pressure from the distension fluid.
 11. The tissue removal device of claim 10, wherein the proximal and distal one-way valves each have a cracking pressure of about 40 mm Hg.
 12. The tissue removal device of claim 1, wherein the proximal and distal one-way valves are configured such that, when the piston is not moving and the uterus is distended by distension fluid, the distension fluid flows through the proximal and distal one-way valves.
 13. The tissue removal device of claim 1, further comprising a valve configured to selectively couple the inner tube lumen with a vacuum source external to the housing.
 14. The tissue removal device of claim 13, wherein the valve is a pinch valve.
 15. The tissue removal device of claim 1, wherein the manual actuator is operatively coupled to the inner tube such that movement of the actuator relative to the housing causes longitudinal movement of the inner tube within the outer tube lumen.
 16. The tissue removal device of claim 15, wherein the longitudinal movement of the inner tube covers a first length greater than a second length of the tissue in-take window.
 17. The tissue removal device of claim 1, wherein the distal one-way valve is at least partially formed in the piston.
 18. The tissue removal device of claim 1, wherein, when the actuator is fully actuated, a volume of the vacuum generation chamber is about three times a volume of the inner tube lumen. 